HOE — Caliper, Ophthalmic Class I

FDA Device Classification

Classification Details

Product Code
HOE
Device Class
Class I
Regulation Number
886.4350
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K881094coopervisionKOI(TM) BLADE GAUGE, MODEL KOI-132April 1, 1988
K813315design research assocCALIPER-OPTHALMICMarch 1, 1982
K820050accutomeKREMER BLADE GAUGEFebruary 24, 1982
K812011koiBLADE GAUGEJuly 28, 1981
K801937aztec medical productsBLEPHAROMETERSeptember 16, 1980
K792383v. mueller o.v. baxter healthcareKELMAN DIPSTICKDecember 11, 1979
K781715edward weckRULER, WECK SCOTTDecember 4, 1978